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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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Book Review: FDA Requirements for Prescription Drug Promotion

Posted 03 September 2013 | By

The pharmaceutical and biotech industry in the US is very heavily regulated under the Food, Drug and Cosmetic Act (and other laws). One specific area of intense scrutiny is the advertising and promotion of prescription drugs and biologics.

understand the fundamentals of the regulatory environment related to advertising and promoting drugs and biologics

understand FDA's position on each different area within this subject matter

learn how FDA enforces the law and regulations through the review and analysis of past and present FDA Warning Letters and untitled letters

avoid making similar mistakes if they apply this knowledge

It is important for the reader to understand that due to the breadth of this field, it was not possible, in the space available, to dive too deeply in many pertinent and related topics (e.g., drug labeling, pharmacoeconomics, medical device promotion, and Department of Justice actions).

It is equally important that readers understand that the focus on just the Center for Drug Evaluation and Research promotional group (the Office of Prescription Drug Promotion) and drug regulations (21 CFR 202.1) does not mean that since biologics are not specifically called out, they are dealt with differently or that different rules apply. It is simply that the laws and regulations are the same and that the Center for Biologics Evaluation and Research promotional team (the Advertising and Promotional Labeling Branch) performs similar functions in similar ways, as they relate to biologics advertising and promotion since biologics are drugs.

FDA Requirements for Prescription Drug Promotion is a thorough compilation of current topics, historical references, FDA enforcement, etc., and provides a robust overview of applicable laws and regulations and should be used as an educational and reference tool by regulatory professionals, marketers and anyone who needs to understand the regulatory landscape around the advertising and promotion of drugs and biologics.

Editor's note: FDA Requirements for Prescription Drug Promotion is available from the RAPS Store both in print and as an e-book for $44.95 for RAPS members, or $54.95, plus shipping, for nonmembers.